Renal hilum surgical simulation system

ABSTRACT

A renal hilum surgical simulation system is provided. The renal hilum surgical simulation system includes simulated tissue layers and simulated renal organs and/or vasculatures. The renal hilum surgical simulation system is adapted for but not limited to laparoscopic donor nephrectomy surgical procedures.

CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation application of U.S.application Ser. No. 16/428,769, filed May 31, 2019, which claimsbenefit of U.S. Provisional Patent Application No. 62/679,568, filed onJun. 1, 2018 and U.S. Provisional Patent Application No. 62/791,450,filed on Jan. 11, 2019, the disclosures of which are hereby incorporatedby reference in their entirety.

BACKGROUND

This application relates to surgical training, and in particular, tosimulated tissue structures and organ models for teaching and practicingvarious surgical techniques and procedures related but not limited tolaparoscopic, endoscopic and minimally invasive surgery.

Laparoscopic surgery requires several small incisions in the abdomen forthe insertion of trocars or small cylindrical tubes approximately 5 to10 millimeters in diameter through which surgical instruments and alaparoscope are placed into the abdominal cavity. The laparoscopeilluminates the surgical field and sends a magnified image from insidethe body to a video monitor giving the surgeon a close-up view of theorgans and tissues. The surgeon watches the live video feed and performsthe operation by manipulating the surgical instruments placed throughthe trocars.

Kidney transplantation is the treatment of choice for patients withend-stage renal disease, which has rapidly increased in the last 10years. There are currently 100,000 patients on the kidney transplantlist, with many waiting 5-10 years for a kidney from a deceased donor.This has led to an increase in live donor nephrectomies, and in turnbecome a vital procedure for transplant surgeons to be proficient in toboth minimize morbidity and mortality for the healthy donor, and toharvest the kidney in an optimal condition for transplantation.Laparoscopic donor nephrectomy (LDN) has since become the preferredsurgical approach, as there are many advantages over open surgery,including decreased hospital stay, postoperative pain and morbidity, andincreased donor satisfaction. However, while there are benefits tolaparoscopic surgery, the complex surgical tasks involved place higherdemands on the skills of the surgeon.

Simulation-based education has greatly enhanced laparoscopic surgicaltraining by providing a safe and effective means for acquiring technicalskills. However, despite the increased need for training on the LDNprocedure, simulation training surgical simulation systems, simulatorsor models are lacking. As a result, trainees are limited to practicingthe procedure in costly animal and cadaver labs or rely on experiencegained through practice on patients in the operating room, which reducesoperating room efficiency. To increase the safe conduct of theoperation, increase the number of practitioners learning LDN, improvethe skills of practitioners, reduce training costs and make training LDNeasier, a LDN simulation model that focuses and isolates one or more ofthe most technically challenging steps in the operation, renal hilumdissection, is desirable and beneficial for reducing the learning curveof transplant trainees allowing them to achieve proficiency faster. Inaddition, a LDN-focused model or surgical simulation system would enabletrainees to practice in a low-risk environment and potentially reducethe need, and associated costs, for animal and cadaver labs.

SUMMARY

In accordance with various embodiments of the present invention, a renalhilum surgical simulation system is provided. The surgical simulationsystem comprises a plurality of penetrable simulated tissue layers, apocket disposed between the plurality of penetrable simulated tissuelayers and encased by the peripheries of the plurality of penetrablesimulated tissue layers, a plurality of fibrous layers disposed betweenthe plurality of penetrable simulated tissue layers and at least one ofa simulated renal organ and vasculature disposed between the pluralityof fibrous layers and enclosed within the pocket.

In accordance with various embodiments, a renal hilum surgicalsimulation system is provided. The system in various embodimentscomprises a first penetrable layer having an upper and lower surface anda second penetrable layer having an upper and lower surface. In variousembodiments, the periphery of the upper surface of the second penetrablelayer is connected to a periphery of the lower surface of the firstpenetrable layer and in various embodiments a pocket is disposed betweenthe first and second penetrable layers. The pocket in variousembodiments is delimited and encased by the peripheries of the first andsecond penetrable layers connected together. A plurality of fibrouslayers in various embodiments are disposed between the first and secondpenetrable layers and in various embodiments at least one simulatedrenal vasculature is disposed between the plurality of fibrous layersand enclosed within the pocket.

In accordance with various embodiments, a renal hilum surgicalsimulation system comprises a first penetrable layer having an upper andlower surface and a second penetrable layer having an upper and lowersurface. In various embodiments, a periphery of the upper surface of thesecond penetrable layer is connected to a periphery of the lower surfaceof the first penetrable layer and in various embodiments a pocketdisposed between the first and second penetrable layers. The pocket invarious embodiments is delimited and encased by the peripheries of thefirst and second penetrable layers connected together. A plurality offibrous layers in various embodiments are disposed between the first andsecond penetrable layers and in various embodiments at least onesimulated renal organ disposed between the plurality of fibrous layersand enclosed within the pocket.

In accordance with various embodiments, a renal hilum surgicalsimulation system comprises a first penetrable layer having an upper andlower surface and a second penetrable layer having an upper and lowersurface. In various embodiments, a periphery of the upper surface of thesecond penetrable layer is connected to a periphery of the lower surfaceof the first penetrable layer and in various embodiments a pocket isdisposed between the first and second penetrable layers. The pocket invarious embodiments is delimited and encased by the peripheries of thefirst and second penetrable layers connected together and a plurality offibrous layers in various embodiments are disposed between the first andsecond penetrable layers. A plurality of simulated renal vasculature invarious embodiments are disposed between the plurality of fibrous layersand enclosed within the pocket and/or at least one simulated renal organin various embodiments is disposed between the plurality of fibrouslayers and enclosed within the pocket.

In accordance with various embodiments, a renal hilum surgicalsimulation system is provided and comprises a simulated renalvasculature and/or a simulated renal organ. In various embodiments, arenal hilum surgical simulation system is provided and comprises atleast one fibrous layer, e.g., batting. In various embodiments, a renalhilum surgical simulation system or renal hilum laparoscopic donornephrectomy surgical simulation system is provided. In variousembodiments, a surgical simulation system is provided and comprises asimulated vasculature, a simulated organ, a simulated renal vasculature,a simulated renal organ and/or any combinations thereof and/orindividually. In various embodiments, the system comprises a firstpenetrable layer having an upper and lower surface and a secondpenetrable layer having an upper and lower surface. In variousembodiments, a periphery of the upper surface of the second penetrablelayer is connected to a periphery of the lower surface of the firstpenetrable layer and in various embodiments, the first and secondpenetrable layers are made of silicone. A pocket in various embodimentsis disposed between the first and second penetrable layers and invarious embodiments, the pocket is delimited and encased by theperipheries of the first and second penetrable layers connectedtogether. A top fibrous layer in various embodiments has an upper andlower surface and in various embodiments is disposed under the firstpenetrable layer with the lower surface of the first penetrable layernext to and in contact with the upper surface of the top fibrous layer.A bottom fibrous layer in various embodiments has an upper surface and alower surface and in various embodiments is disposed above the secondpenetrable layer with the upper surface of the second penetrable layernext to and in contact with the lower surface of the bottom fibrouslayer. A middle fibrous layer in various embodiments has an uppersurface and a lower surface and in various embodiments is positionedbetween the top fibrous layer and the bottom fibrous layer. A firstsimulated renal vasculature in various embodiments is connected to uppersurface of the bottom fibrous layer and the lower surface of the middlefibrous layer and in various embodiments, a second simulated renalvasculature is connected to the lower surface of the top fibrous layerand the upper surface of the middle fibrous layer. In variousembodiments, the top, bottom and middle fibrous layers and the first andsecond simulated renal vasculatures are enclosed within the pocket.

Many of the attendant features of the present invention will be morereadily appreciated as the same becomes better understood by referenceto the foregoing and following description and considered in connectionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present inventions may be understood by reference to the followingdescription, taken in connection with the accompanying drawings in whichthe reference numerals designate like parts throughout the figuresthereof.

FIG. 1 is an exploded view of a renal hilum surgical simulation systemin accordance with various embodiments of the present invention.

FIG. 2 is a top view of portions of the renal hilum surgical simulationsystem in accordance with various embodiments of the present invention.

FIG. 3 is a cross-sectional view of a renal vein and artery inaccordance with various embodiments of the present invention.

FIG. 4A is a side view of portions of the renal hilum surgicalsimulation system in accordance with various embodiments of the presentinvention.

FIG. 4B is a top view of assembled portions of the renal hilum surgicalsimulation system in accordance with various embodiments of the presentinvention.

FIG. 5A is a top view of portions of the renal hilum surgical simulationsystem in accordance with various embodiments of the present invention.

FIG. 5B is a top view of assembled portions of the renal hilum surgicalsimulation system in accordance with various embodiments of the presentinvention.

FIG. 6 is a top view of portions of the renal hilum surgical simulationsystem in accordance with various embodiments of the present invention.

FIG. 7 is a top view of assembled portions of the renal hilum surgicalsimulation system in accordance with various embodiments of the presentinvention.

FIG. 8 is a top view of portions of the renal hilum surgical simulationsystem in accordance with various embodiments of the present invention.

FIG. 9 is a top view of assembled portions of the renal hilum surgicalsimulation system in accordance with various embodiments of the presentinvention.

FIG. 10 is a top view of portions of the renal hilum surgical simulationsystem in accordance with various embodiments of the present invention.

FIG. 11 is a top view of assembled portions of the renal hilum surgicalsimulation system in accordance with various embodiments of the presentinvention.

FIG. 12 is a top view of portions of the renal hilum surgical simulationsystem in accordance with various embodiments of the present invention.

FIG. 13 is an exploded perspective view of the renal hilum surgicalsimulation system in accordance with various embodiments of the presentinvention.

FIG. 14 is an exploded side view of the renal hilum surgical simulationsystem in accordance with various embodiments of the present invention.

FIG. 15 is a top view of portions of the renal hilum surgical simulationsystem in accordance with various embodiments of the present invention.

FIG. 16 is a top view of the renal hilum surgical simulation system inaccordance with various embodiments of the present invention.

FIG. 17 is a perspective view of the renal hilum surgical simulationsystem in accordance with various embodiments of the present invention.

FIG. 18 is a perspective view of the renal hilum surgical simulationsystem in accordance with various embodiments of the present invention.

FIG. 19 is a side view of the renal hilum surgical simulation system inaccordance with various embodiments of the present invention.

DETAILED DESCRIPTION

In a LDN procedure, renal hilum dissection is one of the morechallenging and high-risk steps due to the need to mobilize multiplecritical structures. Currently, there is an unmet need for simulatedmodels or surgical simulation systems that trainees can practice on tobecome proficient at this step of the operation. A simulated model orsurgical simulation system of the renal hilum would reduce the learningcurve by allowing surgical trainees to practice the required dissectionrepeatedly in a low-risk environment. To be effective, the surgicalsimulation system should allow for complete dissection of specificstructures within the renal hilum from a laparoscopic approach, whichincludes one or more of the following simulated anatomy and landmarks tobe present and identifiable in the model or surgical simulation system:kidney, adrenal gland, renal vein, renal artery, ureter, gonadal vein,adrenal vein, lumbar vein, and aorta. These structures should beanatomically correct and/or be made of materials that have a similarsimulated tissue reaction encountered in the LDN procedure. In addition,these structures may be surrounded by simulated dissectible areolartissue of appropriate density to provide realistic tactile feedback.Practice on the surgical simulation system can promote identification ofthe appropriate anatomy and acquisition of appropriate tissue handlingand dissection skills required for the procedure.

The renal hilum surgical simulation system in accordance with variousembodiments allows a trainee to focus on the skills necessary topractice the most challenging steps within a LDN procedure. To provide arealistic procedural training environment, in various embodiments, thesurgical simulation system is positioned appropriately. To furtherenhance the training environment, the surgical simulation system usessimulated materials to represent the various anatomical landmarks aswell as materials to simulate areas of dissectible tissue, which providekey visual and tactile feedback useful for the training of an LDNprocedure. In order to simulate the tactile feel of the anatomicalstructures encountered during the LDN procedure, in accordance withvarious embodiments, specific combinations of materials, construction,and design have been chosen for various components found within thesurgical simulation system.

Turning now to FIG. 1 , an exploded perspective view of a renal hilumsurgical simulation model or system 10 according to various embodimentsof the present invention is shown. The inner contents (anatomicalstructures and fibers) of the surgical simulation system 10 areencapsulated between two layers of silicone, a top penetrable layer 12and a bottom penetrable layer 14, that are adhered together to create aclosed pocket. Inside the pocket, the top outermost layer is a topfibrous layer 16 constructed of a simulated dissectible tissue area madeof multiple layers of sheets of polyester fibers, e.g., batting, adheredusing small amount of silicone or adhesive that the surgeon is todissect or cut through in order to uncover and reach the anatomicalstructures encountered in the LDN procedure. This dissection areacomprising of the multiple layers of polyester fibers, such as ahalf-fibrous layer 18, that are adhered together, fiber to fiber, e.g.,batting to batting, as well as fiber, e.g., batting, to anatomicalsimulated structures are created to demonstrate the varying densities ofthe anatomy found in the body. In accordance with various embodiments,one or more of the layers are planar and/or stacked relative to eachother.

In accordance with various embodiments, a layer of simulated anatomicallandmarks is provided. The simulated anatomical landmarks in variousembodiments comprise a simulated kidney 20, adrenal gland 22, ureter 24,and/or aorta 26. While none of these components should be dissected orcut during the simulated procedure, these landmarks are included in thesurgical simulation system 10 to help orientate and/or educate thetrainee. For example, the simulated ureter 24 should be identified butnot touched, and is used as a tool to navigate to the location of thegonadal vein 28. Although the simulated landmarks should not be touchedor manipulated by the trainee, one or more of these simulated anatomicalstructures includes one or more visual characteristics such as size,shape, color and/or any combination thereof, to simulate anatomy and/orto pose as indicators to allow for orientation within the simulatedenvironment. In various embodiments, one or more of these simulatedanatomical structures also comprises one or more tactilecharacteristics, such as texture, resiliency, elasticity and/or anycombination thereof to further enhance identification of the simulatedlandmarks and/or as assessment and/or educational indicators. Forexample, in various embodiments, one or more of the simulated landmarksholds its shape until cut or excessively manipulated and thus ifinadvertently cut or otherwise unduly manipulated, the simulatedlandmarks would reflect this treatment and thereby providing anassessment for an evaluator and/or educational indicator for a trainee.

During the simulated procedure, the simulated gonadal vein 28, adrenalvein 30, and lumbar vein 32 are located and circumferentially dissected,or skeletonized. During this skeletonization, the surgeon may pull up onthe veins in order to make cuts and dissect through the fibers orbatting. This is one of the most challenging steps in the procedure asthe veins are very fragile and will break or tear if incised or if toomuch force is put on them. For surgeons to become comfortable orproficient in these steps of the procedure, they must understand theforce required to manipulate the veins during dissection without harmingthem and thus the necessity to simulate the fragility of the veins.

In accordance with various embodiments, the simulated gonadal vein 28,adrenal vein 30, and/or lumbar vein 32 are made of a silicone orsilicone foam that is molded into thin flat structures to simulatefragility of the various veins. It should be noted that gonadal,adrenal, and lumbar veins found within the human body are hollowcylindrical structures through which blood flows and have diameters of 3mm, 4 mm, 2 mm respectively. As such, in accordance with variousembodiments, while the simulated gonadal vein 28, adrenal vein 30,and/or lumbar vein 32 are not exact replicas of anatomy, e.g., in sizeand/or shape, these simulated veins are provided, for example, in sizeand/or shape along with the choice of material, e.g., silicone, to aidin the manufacturing process and replicate the tactile feel of thecorresponding structures.

In various embodiments, the simulated gonadal, adrenal, and lumbarveins, 28, 30, 32 includes one or more cuts or notches 50 along theirlengths in predetermined locations as shown in FIG. 2 . Thesepredetermined notches 50 create weak or break points at specificlocations, allowing the simulated vessels to simulate the fragility ofsuch vessels. Additionally, in various embodiments, if excessive forceor manipulation is applied to the simulated veins, the simulated veinswill separate at one or more of the notches 50. A separated or tornvessel can provide an assessment and/or educational indication for orregarding the trainee's specific performance of or during the simulatedprocedure. Furthermore, the location of where the tear occurred, asindicated at a particular notch or weak point, can further assist inproviding a more detailed assessment and/or educational indicator of theforce or manipulation applied to the torn simulated vessel. It shouldhowever be noted that simulated vessels with predetermined notches mayinhibit assessment of the simulated vessels after the procedure isperformed, e.g., identifying new versus old or pre-installed notches mayprove difficult, and as such predetermining the location and/or size ofthe notches or weak points can assist in reducing or eliminating thisinhibition.

In various embodiments, the simulated lumbar vein within the surgicalsimulation system is under tension. The simulated lumbar vein, invarious embodiments, is pulled taut and attached to the back of themodel or surgical simulation system, putting it on tension. Placing thesimulated lumbar vein under tension allows the simulated vein orportions thereof to snap when nicked or excessively tugged duringcircumferentially dissection. This snapping simulates or represents thefragility of the simulated lumbar vein as the amount of force used tosnap the simulated vessel is similar to the amount of force to similarlyaffect a non-simulated lumbar vein.

In various embodiments, the surgical simulation system 10 comprises asimulated renal vein 34 and a simulated renal artery 36. The simulatedrenal vein 34 and renal artery 36 are separated from the surroundingfibers or batting (i.e. skeletonized) during the simulated procedure.The simulated renal vein 34 and renal artery 36 have much largerdiameters (approximately 1.2 cm and 6 mm, respectively) than that of thesimulated gonadal, adrenal, and lumbar veins 28, 30, 32 giving them moreintegrity and/or strength to simulate the tactile differences in thesimulated renal vein 34 and renal artery 36.

In accordance with various embodiments, with reference to FIG. 3 , theillustrated simulated renal artery 36 has a smaller overall diameter butthicker wall relative to the simulated renal vein 34 having a largerdiameter and thinner wall. In various embodiments, the simulated renalartery and vein are made of silicone and, in various embodiments, thesimulated renal artery comprises a thick layer of silicone providing athicker wall thickness of the simulated vessel. In various embodiments,the layer of silicone is made thicker by applying multiple thin layersor coats of wet or dry silicone. As a result of a thicker wall, thevessel will be harder to penetrate, i.e., the simulated renal artery isharder to penetrate versus the simulated renal vein. The simulated renalvein, in various embodiments, has a thin layer of silicone to provide athin wall thickness. As a result, the vessel, e.g., the simulated renalvein, will be easier to puncture or nick.

Providing a contrast in structural integrity of the renal vein and renalartery further provides or enhances the simulation and/or the trainingand/or assessment indications as the tactile force allowed during thesimulated procedure to circumferentially dissect around each of thestructures without puncturing or otherwise unduly disrupting them isdifferent for each vessel. In various embodiments, the thinner walls ofrenal vein 34 are fragile and/or made with a thinner layer of material.In contrast, in various embodiments, the simulated renal artery 36 ismade of a thicker layer or layers of material. Both vessels are made ofor molded from silicone and/or a similar fragile material that will holdits shape including conductive material.

In various embodiments, the simulated renal vein 34 and/or renal artery36 are filled with fluid or the like to further mimic anatomy and/or forassessment or training indicators. For example, if either of thevasculature is punctured, fluid may be expelled or trickle out of thesimulated vessels and thereby provide a visual indication of puncturedvasculature and potentially indicating further training or decreasedproficiency of the trainee.

In FIGS. 4A-B, the simulated adrenal vein 30, gonadal vein 28, andlumbar vein 32 are adhered or otherwise attached to the simulated renalvein 34 at a renal vein adhesion area 52 and, in various embodiments,through adhesion of silicone to silicone. The renal vein adhesion area52 is depicted by a rectangular box in FIG. 4B. Even though the adhesionarea is depicted as a rectangular shape, the adhesion area may be anyshape. The attachment area 52 is illustrated or referred throughout as aguide and as an exemplary way to show where the components are adheredor otherwise attached or where adhesive or the like is applied. Invarious embodiments, the simulated gonadal vein 28, adrenal vein 30, andlumbar vein 32, are molded separately and are minimally and/or weaklyadhered to the renal vein 34 to increase the fragility of the simulatedveins for, e.g., assessment and/or training, when the simulated vesselis put on tension and dissected around. The weak adhesion in variousembodiments is achieved by using a weak adhesive or similar attachment,such as a silicone with a softer durometer, and/or removing connector 33and attaching the simulated veins 28, 30, 32 directly to the simulatedrenal vein 34.

With reference to FIGS. 5A-B, a second vasculature subassembly isillustrated in accordance with various embodiments. As illustrated, thesimulated renal artery 36 is adhered or otherwise attached to thesimulated aorta 26 by a silicone-to-silicone adhesion and, in variousembodiments, with consistent hard durometer silicone. In variousembodiments, wet silicone is employed as an adhesive and allowed to cureto solidify the connection. The aorta adhesion area 52 is depicted by arectangular box in FIG. 5B. In various embodiments, the simulated aorta26 has a semi-cylindrical shape as seen for example in FIG. 14 .

Turning now to FIG. 6 , a back fibrous layer 38 is provided. The backfibrous layer 38 in various embodiments is made of or includes batting.In various embodiments, the back fibrous layer is a rectangular,substantially planar layer of polyfill or other fibrous material. Theback fibrous layer 38 includes a hole or opening 54 through which thelumbar vein 32 is passed. The opening 54 is unique to the surgicalsimulation system 10 and is not anatomically correct. The secondvasculature subassembly comprising the renal artery 36 and aorta 26 isadhered to the back or first fibrous layer 38 using adhesive as shown inFIG. 7 . The adhesion area 52 is shown to be substantially under theentire second subassembly.

Turning now to FIG. 8 , in accordance with various embodiments, a secondfibrous layer 40 is adhered to the simulated renal artery 36 and aorta26 of the second vasculature subassembly. The second fibrous layer 40 ismade of or includes batting. In various embodiments, the second fibrouslayer is a rectangular, substantially planar layer of polyfill or otherfibrous material. The second fibrous layer 40 is also adhered to theback or first fibrous layer 38 with an adhesion area 52 indicated by thelarge rectangle. The second fibrous layer 40 also contains a hole oraperture 56 extending from the top and through to the bottom surface ofthe second fibrous layer 40. The simulated lumbar vein 32 passes throughthis hole 56 and the hole 54 in the back fibrous layer 38 and, as such,the holes 54, 56 are aligned when the layers are stacked such that theirperimeters are substantially congruent to fit inside the pocket. Turningnow to FIG. 9 , the first vasculature assembly, comprising the simulatedgonadal vein 28, adrenal vein 30, lumbar vein 32 and renal vein 34, areadhered to the second fibrous layer 40 with an adhesion area 52 beingunder the renal vein 34, adrenal vein 30 and gonadal vein 28 as shown inFIG. 9 with the adhesion area 52 shown by three rectangles. Thesimulated lumbar vein 32 is passed through the holes 56 and 54 in thefibrous layers 40, 38.

Turning now to FIG. 10 , the simulated kidney 20, ureter 24 and adrenalgland 22 are connected to the simulated renal vein 34 and adrenal vein30 and to the second fibrous layer 40. The simulated ureter 24 isadhered to or otherwise attached to the back of the simulated kidney 20.The kidney 20 is adhered to the top end of the simulated renal vein 34as well as the second fibrous layer 40. The simulated ureter 24 isadhered to the second fibrous layer 40. The simulated adrenal gland 22is adhered to the simulated adrenal vein 30 as well as the secondfibrous layer 40. The simulated adrenal gland 22 is not adhered to thesimulated kidney 20. The adhesion areas 52 are demonstrated by therectangular shapes in FIG. 10 and the non-adhesion area 58 between theadrenal gland 22 and the kidney is demonstrated by the ellipse in FIG.10 .

Turning now to FIG. 11 , the half fibrous layer 18 is adhered to thesimulated kidney 20, the simulated adrenal gland 22, the adrenal vein30, the renal vein 34, and the second fibrous layer 40. The adhesionarea 52 is shown by a rectangle substantially completely underneath thehalf fibrous layer 18. The half fibrous layer 18 is provided to simulatea denser dissectible areolar tissue found within a patient. In variousembodiments, the half fibrous layer 18 is created from cutting thelarger piece of fibrous material, e.g., batting, in half, length-wiseand pulling apart the layers of the batting to create a thinner piece toadd to the density of the dissectible tissue. In accordance with variousembodiments, the fibers or fibrous material encapsulate and surround oneor more or every simulated anatomical structure. The multiple layers offibrous material, e.g., batting, provide varying density of dissectiblematerial in which a surgeon has to navigate. As stated previously, thesimulated lumbar vein 32 passes through the holes 54, 56 in the fibrouslayers 38, 40. When the surgical simulation system 10 is flipped over,back side facing up, as shown in FIG. 12 , the simulated lumbar vein 32is pulled through the holes 54, 56 to expose it on the back side.

With reference to FIGS. 12-13 , the surgeon must circumferentiallydissect around the renal vein 34. In accordance with variousembodiments, the contents of the surgical simulation system 10 areencapsulated between the top silicone layer 12 and the bottom siliconelayer 14. The bottom silicone layer 14 of the surgical simulation system10, in various embodiments, is constructed of uncured silicone, which isadhered to the top fibrous layer 16 around the outside border, creatinga pocket upon curing together with all of the components retained by andlocated inside the pocket. Because the bottom silicone layer 14 ofsilicone is uncured during manufacturing of the assembly, the backfibrous layer 38 will also adhere to the wet silicone. If the backfibrous layer 38 becomes too saturated with uncured silicone, it canundesirably start to adhere the simulated renal artery 36 and aorta 26to the bottom silicone layer 14, which would prevent the ability of thesurgeon trainee to circumferentially dissect around the renal artery ofthe simulated LDN procedure. To prevent or reduce this undesirableadhesion, an adhesion blocker 42 is used to ensure that the simulatedrenal artery 36 can be dissected circumferentially around as shown inFIG. 13 with the dissection area 60 demarked with a ellipse. Theadhesion blocker 42, in various embodiments, is made of a siliconesheet, molded to the approximate thickness of the bottom silicone layer14, and cut to the size of the renal artery 36 to prevent any undesiredadhesion. In various embodiments, the adhesion blocker 42 is placed orused such that it does not obstruct the lumbar vein 32, since the lumbarvein 32 will ultimately be adhered to the back of the surgicalsimulation system 10, bottom silicone layer 14. The adhesion blocker 42,in various embodiments, is adhered to the back fibrous layer 38 shown,for example, by the rectangular adhesion area, without excess forceapplied, so as not to saturate the fibrous material, e.g., batting,through and adhere the simulated renal artery 36 or aorta 26.

With reference to FIG. 14 , the simulated lumbar vein 32, in variousembodiments, is adhered to the simulated renal vein 34 and then passesthrough the second fibrous layer 40 and back fibrous layer 38 andadhered to the bottom silicone layer 14. In accordance with variousembodiments, the adherence of the lumbar vein 32 to the bottom siliconelayer 14 occurs while the model or surgical simulation system contentsare placed on the uncured bottom silicone layer 14. Upon curing of thebottom silicone layer 14, the contact of the lumbar vein 32 with theuncured bottom silicone layer 14 will form the necessary adhesion. Invarious other embodiments, the lumbar vein 32 is adhered to the secondfibrous layer 40 and back fibrous layer 38 at their respective holes 56,54.

In various embodiments, in the surgical simulation system, the layersare adhered together by intertwining the surrounding fibrous layers,holding simulated structures in place with or without the use ofsilicone or silicone adhesive.

In various embodiments, fibers of the fibrous, e.g., batting, layers aremesh through one another to create a knit matrix and/or when pushthrough the silicone components a slight adhesion of batting to siliconeis created. As such, adequate adhesion of tissue (e.g., batting) to theorgans (e.g., silicone) for a surgeon to dissect through in thesimulated procedure is provided. Such knit matrix can also avoid orreduce the use of silicone glue layers that can be difficult to controlfor consistency throughout the surgical simulation system or causeunwanted residues.

With reference now to FIGS. 15 and 16 , in various embodiments, toensure identification of the simulated ureter 24 and gonadal vein 28,the simulated ureter 24 and gonadal vein 28 are visible through theborder/perimeter 62 of the surgical simulation system 10. In accordancewith various embodiments, the border/perimeter 62 is formed by the topsilicone layer 12 adhering together with the bottom silicone layer 14 toform a pocket 64. The simulated ureter 24 and gonadal vein 28 arevisible through the top silicone layer 12 at the border/perimeter 62 ofthe surgical simulation system 10. These landmarks pose as an indicatoras to where the surgeon should start dissection of the surgicalsimulation system 10. In order for these landmarks to be visible throughthe border 62, the simulated ureter 24 and gonadal vein 28 extendoutwardly past the fibrous layers and into the border, highlighted bycircle 63 in FIGS. 15-16 . In various other embodiments, the colorand/or opacity of the top silicone layer 12 is distinguished withrespect to the simulated ureter 24 and gonadal vein 28 to allow forvisibility of the landmarks through the top silicone layer 12.

With reference to FIGS. 17-19 , in accordance with various embodiments,the renal hilum dissection surgical simulation model 10 may include twoor more holes along the border 62 for mounting on a stand 66 having abase 68 with at least two upstanding posts 70 extending upwardly fromthe base 68. The posts 70 are passed through the holes in the border 62.The stand 66 with the surgical simulation model 10 can then be locatedinside a cavity of a laparoscopic trainer 72 for the procedural practiceto begin. The trainer defines a cavity between a top cover and a base.The cavity is obscured from direct view by the practitioner and a scopeis inserted through the top cover to capture a live video feed of thecavity, which is displayed on a monitor to the practitioner. Thepractitioner or trainee inserts various instruments through the topcover and performs the simulated procedure on the surgical simulationsystem 10 inside the cavity. The stand 66 serves to support the surgicalsimulation model or system 10 inside the trainer 72. In variousembodiments, the surgical simulation system 10 contains one or moreholes or apertures in each of the top two corners of the border 62.These holes interface with the posts 70. In various embodiments, thestand 66 includes four posts 70. In various embodiments, the border 62is made from elastic silicone material that stretches and returns to itsoriginal shape and the holes of the border are stretched to fit over thepost 70 and then return to a tight fit to secure the surgical simulationsystem 10 into place on the posts 70 of the base 68. The placement ofthe holes on the posts 70, along with the angled position of a flap 44,allow for the surgical simulation system 10 to be placed in a variety ofangles with respect to the base 68 that may be necessary to complete thesimulated procedure. In various embodiments, in order to stabilize theupper corners of the surgical simulation system 10, clips 74 within thetrainer 72 are used to pull the surgical simulation system uprightand/or hold it in position. In accordance with various embodiments, astand or stable structure and/or similar attachments to the surgicalsimulation system and/or the trainer may hold the surgical simulationsystem stable in an angled position for the simulated surgicalprocedure.

In various embodiments, the surgical simulation system includes, isintegrated or is embedded with a frame that supports, suspends and/orangles the surgical simulation system and in various embodiments inorder to replicate or simulate the angled position of a patient. Thesurgical simulation system is removably attached to the frame and invarious embodiments, the frame is removably attached to a surgicaltrainer. In such embodiments, the apertures within the border and/or theadditional portion provided by the border may be removed along with theflap, the associated attachment and/or the additional portions providedby the surgical simulation system providing the flap, attachment and/orborder.

During an LDN procedure, the patient is situated lying down on theirside with a slight backwards tilt. In order to replicate or simulate theangled position of a patient, the renal hilum dissection surgicalsimulation system 10, according to various embodiments, incorporates aflap 44 designed to be used as a support stand. Looped side of ahook-and-loop type fastener 46, such as VELCRO®, is adhered to the flap44 and configured to mate with the opposite or hooked side of thehook-and-loop type fastener 46 located on the bottom floor of thetrainer 72. The flap 44 extends from the bottom side of the surgicalsimulation system 10 and in various embodiments, is constructed a softand flexible yet durable silicone that allows it to bend whilemaintaining its structural integrity. In various embodiments, the flap44 is flexible so that two pieces of the hook-and-loop type fastener 46can mate, while creating a bent stand for which to hold the surgicalsimulation system into the desired angle and position within thelaparoscopic trainer 72. The flap 44 is used in conjunction with orwithout the stand 66. Attachment of the flap 44 to the floor of thetrainer may vary and in various embodiments, the hook-and-loop typefastener may be replaced with or further include, for example, one ormore snaps, magnets, posts or clips, and/or may extend through, attachto or be adhered to an intermediary component, e.g., an extension ofbase 68, between the attachment/surgical simulation system and the floorof the trainer. The attachment of the surgical simulation system allowsthe surgical simulation system to be removable and thus easesreplace-ability, repositioning or reorientation of the surgicalsimulation system. Such attachment or positioning of the variousportions of the surgical simulation system relative to the trainerensures that the orientation or angled position of the surgicalsimulation system replicates the orientation or position of the patientand in various embodiments ensures the tactile feedback, flexibility orother features provided by the surgical simulation system are notsacrificed and/or the simulated LDN procedure compromised.

In various embodiments, other variations to the surgical simulationsystem 10 may include alteration of the anatomical structures inside thepocket to include abnormal, diseased, or varying anatomy. Such anatomycould include the right renal hilum or the inclusion of additionallumbar veins and/or tumors. In other embodiments, the surgicalsimulation system 10 is dipped or soaked in water or other liquid tobetter represent the environment of a patient. For example, when thefibrous or batting layers become saturated with liquid they tend tobecome denser and more adhered. This allows, in various embodiments, formore applicable and accurate representation of the difficulty of the LDNprocedure. Instead of a liquid such as water, the pocket 64 could alsobe filled with a gel like substance.

In various embodiments, the arrangement and/or composition of thevarious portions and components are provided to vary the difficulty ofthe surgical simulation system and thereby vary the simulated surgicalprocedure to enhance surgical training and surgical skill assessment.Such examples are described throughout the description and provided inthe claims that may seem arbitrary but again are included or excluded tovary and adjust the difficulty the surgical simulation system to enhancesurgical training and skill assessment. Some of these examples caninclude varying fibrous layer densities, exaggerating or underplayingsimulated renal vasculature and/or organ shapes, dimensions and/ortactile response, saturating fibrous layers with liquid, creatingsimulated vasculature paths, e.g., a simulated renal vasculaturethreaded or extended through at least one opening in one or more ordifferent fibrous layers, and/or varying the coloring and/or compositionof the simulated renal vasculature, organs and/or surroundingstructures.

In various embodiments, both sides or layers of the surgical simulationsystem are penetrable to ensure or further assess surgical skill suchthat if mishandling or manipulation of the simulated tissue, e.g., toomuch force is used, a noticeable puncture or opening in the opposingside of the surgical simulation system would be visible. Likewise, thethickness or distance between the layers are minimal, e.g., a fractionof the length or width of the surgical simulation system or the pocketcontained therein, to further test or enhance the assessment of thesurgical skill or effective operation of the simulated surgicalprocedure.

In various embodiments, the surgical simulation system is so confined tolimit the working space available to simulate the surgical procedures.Likewise, the size of the pocket, for example, can be modified tofurther limit the operational space and thereby increase thedifficulties of the simulated surgical procedure. Additionally, thenumber and/or size of the components and combinations thereof arefurther limited to enhance portability of the surgical simulationsystem, operation within a trainer, e.g., a portable laparoscopictrainer and/or further focus the surgical trainee on the specificsimulated procedure. Similarly, omitted features or reduction of sizesor shapes are provided to enhance the surgical simulation system, e.g.,increase difficulties or focus on the specific simulated surgicalprocedure, even though such differences or changes may not beanatomically correct. In various embodiments, the surgical simulationsystem includes at least one simulated renal vasculature, e.g., renalvein, renal artery, and/or the like and/or other vasculature/vesselsprovided herein, and/or at least one simulated renal organ, e.g.,adrenal gland, kidney and/or the like and/or other organs/glandsprovided herein.

The above description is provided to enable any person skilled in theart to make and use the surgical simulation system or systems andperform the methods described herein and sets forth the best modescontemplated by the inventors of carrying out their inventions. Variousmodifications, however, will remain apparent to those skilled in theart. It is contemplated that these modifications are within the scope ofthe present disclosure. Different embodiments or aspects of suchembodiments may be shown in various figures and described throughout thespecification. However, it should be noted that although shown ordescribed separately each embodiment and aspects thereof may be combinedwith one or more of the other embodiments and aspects thereof unlessexpressly stated otherwise. It is merely for easing readability of thespecification that each combination is not expressly set forth.

Although the present invention has been described in certain specificaspects, many additional modifications and variations would be apparentto those skilled in the art. It is therefore to be understood that thepresent invention may be practiced otherwise than specificallydescribed, including various changes in the size, shape and materials,without departing from the scope and spirit of the present invention.Thus, embodiments of the present invention should be considered in allrespects as illustrative and not restrictive.

1. A renal hilum surgical simulation system comprising: a firstpenetrable layer having an upper and lower surface; a second penetrablelayer having an upper and lower surface, a periphery of the uppersurface of the second penetrable layer connected to a periphery of thelower surface of the first penetrable layer; a pocket disposed betweenthe first and second penetrable layers, the pocket being delimited andencased by the peripheries of the first and second penetrable layersconnected together; a plurality of fibrous layers disposed between thefirst and second penetrable layers; a plurality of simulated renalvasculature disposed between the plurality of fibrous layers andenclosed within the pocket; and at least one simulated renal organdisposed between the plurality of fibrous layers and enclosed within thepocket.
 2. The system of claim 1 wherein at least one of the pluralityof simulated renal vasculature extends through the plurality of fibrouslayers.
 3. The system of claim 2 wherein the at least one of theplurality of simulated renal vasculature extends through an aperturedisposed in at least one of the plurality of fibrous layers.
 4. Thesystem of claim 3 wherein at least one of the plurality of simulatedrenal vasculature extends through a first aperture disposed in a firstfibrous layer of the plurality of fibrous layers and a second aperturedisposed in a second fibrous layer of the plurality of fibrous layers.5. The system of claim 4 wherein at least one of the plurality ofsimulated renal vasculature has a hemispherical shape.
 6. The system ofclaim 1 wherein a first simulated renal vasculature of the at least oneof the plurality of simulated renal vasculature extends along a width ofthe pocket and a second simulated renal vasculature of the at least oneof the plurality of the simulated renal vasculature extendsperpendicular to the first simulated renal vasculature and along alength of the pocket.
 7. The system of claim 1 wherein the at least onesimulated renal vasculature includes a plurality of notches spaced fromeach other.
 8. The system of claim 1 wherein the at least one simulatedrenal vasculature includes at least one notch disposed on an upperportion of the at least one simulated renal vasculature and at least onenotch disposed on a lower portion of the at least one simulated renalvasculature.
 9. The system of claim 1 wherein at least one of theplurality of fibrous layers is a water saturated fibrous layer.
 10. Thesystem of claim 1 wherein at least one of the plurality of fibrouslayers is a multi-layered silicone batting.
 11. The system of claim 1wherein at least one of the plurality of fibrous layers includes a firstfibrous layer having a width and length equal to a width and length ofthe pocket and a second fibrous layer adhered to the first fibrouslayer, the second fibrous layer having a width and length half of thewidth and length of the pocket.
 12. The system of claim 1 wherein the atleast one simulated renal vasculature includes a first simulated renalvasculature and a second simulated renal vasculature, the firstsimulated renal vasculature being more puncture resistant than thesecond simulated renal vasculature.
 13. The system of claim 1 whereinthe at least one simulated renal vasculature includes a first simulatedrenal vasculature and a second simulated renal vasculature, the firstsimulated renal vasculature minimally adhered to the second simulatedrenal vasculature relative to the second simulated renal vasculatureadhered to a fibrous layer of the plurality of fibrous layers.
 14. Arenal hilum simulation system comprising: a first penetrable layerhaving an upper and lower surface; a second penetrable layer having anupper and lower surface, a periphery of the upper surface of the secondpenetrable layer connected to a periphery of the lower surface of thefirst penetrable layer, the first and second penetrable layers beingmade of silicone; a pocket disposed between the first and secondpenetrable layers, the pocket being delimited and encased by theperipheries of the first and second penetrable layers connectedtogether; a top fibrous layer having an upper and lower surface, the topfibrous layer disposed under the first penetrable layer with the lowersurface of the first penetrable layer next to and in contact with theupper surface of the top fibrous layer; a bottom fibrous layer having anupper surface and a lower surface, the bottom fibrous layer disposedabove the second penetrable layer with the upper surface of the secondpenetrable layer next to and in contact with the lower surface of thebottom fibrous layer; a middle fibrous layer having an upper surface anda lower surface, the middle fibrous layer positioned between the topfibrous layer and the bottom fibrous layer; a first simulated renalvasculature connected to upper surface of the bottom fibrous layer andthe lower surface of the middle fibrous layer; and a second simulatedrenal vasculature connected to the lower surface of the top fibrouslayer and the upper surface of the middle fibrous layer, the top, bottomand middle fibrous layers and the first and second simulated renalvasculatures being enclosed within the pocket.
 15. The system of claim14 wherein the middle fibrous layer includes an aperture extendingbetween the upper surface of the middle fibrous layer and the lowersurface of the middle fibrous layer and the bottom fibrous layerincludes an aperture extending between the upper surface of the bottomfibrous layer and the lower surface of the bottom fibrous layer.
 16. Thesystem of claim 15 further comprising a third simulated renalvasculature connected to the second renal vasculature, the thirdsimulated renal vasculature extending through the aperture of the middlefibrous layer, pass the first simulated renal vasculature, through theaperture of the bottom fibrous layer and in contact with the secondpenetrable layer.
 17. The system of claim 14 wherein the top fibrouslayer is denser than the bottom fibrous layer.
 18. The system of claim17 wherein the bottom fibrous layer is denser than the middle fibrouslayer.
 19. The system of claim 14 further comprising a fourth simulatedrenal vasculature connected to the second simulated renal vasculatureand extending away from the second simulated renal vasculature andoutside the pocket.
 20. The system of claim 19 further comprising asimulated renal organ disposed between the lower surface of the topfibrous layer and the upper surface of the middle fibrous layer, the topfibrous layer, the middle fibrous layer and the bottom fibrous layerbeing made of batting and the simulated renal organ being made ofsilicone.